Optimal Pacing Rate for Cardiac Resynchronization Therapy

Last updated: October 9, 2024
Sponsor: Medstar Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

Pacing rate of 60 bpm

Pacing rate of 80 bpm

Clinical Study ID

NCT06445439
STUDY00006952
  • Ages 18-90
  • All Genders

Study Summary

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older

  2. History of persistent or permanent atrial fibrillation

  3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years ofstudy start

  4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5years of study start

  5. LVEF ≥ 50%

  6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/mL in the last 24months

  7. Clinical HF diagnosis or NYHA class II or higher

  8. Able to provide informed consent

Exclusion

Exclusion Criteria:

  1. LVEF <50%

  2. Wide QRS (greater than 150ms)

  3. Isolated RV pacing

  4. Severe valvular disease

  5. Severe coronary artery disease as defined by one of the following:

  6. ACS or PCI within 1 year

  7. Any angina (CCS class 1+)

  8. Unrevascularizable severe CAD (>70% stenosis in 1+ major vessels and/or basedon functional assessment)

  9. ESRD

  10. Significant primary pulmonary disease on home oxygen

  11. Major orthopedic issues, such as being wheelchair bound and/or unable to perform asix-minute walk test

  12. Ventricular ectopy >15% premature ventricular contractions (PVC)

  13. End stage cancer diagnosis

  14. Life expectancy less than one year

  15. Palliative or hospice care

  16. Hypertrophic cardiomyopathy (HCM)

  17. Uncorrected ventricular septal defect

  18. Infiltrative cardiomyopathy (CM)

  19. Uncontrolled hypertension as defined by blood pressure >160/100 mm Hg on twomeasurements ≥15 minutes apart

  20. Hemoglobin <7 g/dL

  21. Age >90 years old

  22. Pregnant or intends to become pregnant

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Pacing rate of 60 bpm
Phase:
Study Start date:
December 19, 2023
Estimated Completion Date:
August 31, 2025

Study Description

Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test.

The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.

Connect with a study center

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • MedStar Southern Maryland Hospital

    Clinton, Maryland 20735
    United States

    Active - Recruiting

  • MedStar Heart and Vascular Office at Fairfax

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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